In this first installment of Mintz Levin’s Health Care Fraud Enforcement Defense Group’s periodic updates on health care enforcement activities in 2012,Brian Dunphy, Hope Foster, Samantha Kingsbury, Tracy Miner, and Stephanie Willis focus on significant civil settlements, criminal prosecutions, and regulatory developments that occurred in the first quarter of 2012. This update follows our Year in Review series focusing on… Continue Reading
Category Archives: Fraud & Abuse
Subscribe to Fraud & Abuse RSS FeedAbbott Labs to Pay $1.6 Billion to Settle Consumer Protection and Misbranding Claims
Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & LitigationAbbott Laboratories (Abbott), an Illinois company, will pay over $1.6 billion in penalties to the federal government and several states related to its alleged illegal promotion of the prescription drug Depakote for off-label uses, as announced by the settling parties on May 7, 2012. Specifically, the government has alleged that the Company: marketed Depakote, in nursing… Continue Reading
Medicare Fraud Strike Force Bust Involves Highest Amount of False Billings in a Single Takedown
Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation2012 is already a record-breaking year in health care fraud enforcement. This week Attorney General Eric Holder and Secretary of the Department of Health and Human Services (HHS) Kathleen Sebelius announced the biggest takedown in the history of the Medicare Fraud Strike Force (Strike Force) in terms of Medicare dollars at stake. The Strike Force… Continue Reading
Open Letter from Senate Finance Committee Seeks Fraud-Fighting Input
Posted in Fraud & Abuse, Health Care Reform, State & Federal Audits, Investigations & LitigationYesterday the Senate Finance Committee posted an open letter on its website to the health care sector soliciting industry stakeholder insights on ways to combat fraud, waste, and abuse in the Medicare and Medicaid programs. This letter comes on the heels of an April 25th hearing at which the members questioned government officials from the Department of Health and… Continue Reading
OIG Advisory Opinion 12-05 Approves Consumer Rewards Program
Posted in Fraud & Abuse, Health Care Reform, Payors & PBMs, PharmaciesWritten by Theresa Carnegie In OIG Advisory Opinion 12-05, the OIG found that a consumer rewards program (the “Program”) offered by a supermarket chain with in-store and independent pharmacies (the “Requestor”) would not be subject to enforcement under the Anti-Kickback Statute (the “Kickback Statute”) or the beneficiary inducement prohibition found in the civil monetary penalties… Continue Reading
Senate Committee Holds Hearing on Health Care Fraud Enforcement
Posted in Fraud & Abuse, Health Care Reform, State & Federal Audits, Investigations & LitigationWritten by: Stephanie Willis and John Custer, ML Strategies Intern A hearing titled Anatomy of a Fraud Bust: From Investigation to Conviction held by the Senate Committee on Finance (Committee) on April 24th allowed federal health care agencies to both tout their fraud-fighting successes, and defend their failure to implement all of the fraud-fighting initiatives created by… Continue Reading
Industry Trends in Criminal Health Care Fraud Enforcement
Posted in Fraud & Abuse, Health Care Reform, State & Federal Audits, Investigations & Litigation, UncategorizedMintz Levin’s Health Care Enforcement Defense Group has issued a new Client Advisory: Industry Trends in Criminal Health Care Fraud Enforcement – Part III in a Continuing Series on Health Care Enforcement. Written by Hope Foster, Tracy Miner, Stephanie Willis, Samantha Kingsbury, and Brian Dunphy, this third and final installment reviewing criminal health care fraud enforcement activities in 2011 and… Continue Reading
HHS Issues Report to Congress on the Self-Referral Disclosure Protocol
Posted in Clinical Laboratories, Fraud & Abuse, Health Care Reform, Hospitals & Health Systems, Physicians, State & Federal Audits, Investigations & LitigationWritten by Tom Crane and Brian Dunphy On March 23, 2012, the Department of Health and Human Services (HHS) issued its statutorily required report to Congress (Report) describing the implementation of the Medicare Physician Self-Referral Disclosure Protocol (SRDP) and the status of disclosures under the SRDP to date. The SRDP was authorized by the Affordable Care… Continue Reading
OIG Approves Wholly Owned Subsidiary GPO Arrangement
Posted in Fraud & Abuse, Hospitals & Health SystemsWritten by Theresa Carnegie and Nili Yolin In Advisory Opinion 12-01, the Office of Inspector General for the Department of Health and Human Services (OIG) analyzed a proposal from a nonprofit health system (the “System”) to form a group purchasing organization (the “Proposed GPO”) for the benefit of the System’s affiliates and subsidiaries. … Continue Reading
Client Alert – The False Claims Act: The Impact in 2012
Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation, UncategorizedMintz Levin has issued a Client Alert: The False Claims Act: The Impact in 2012 - Part II in a Continuing Series on Health Care Enforcement. Written by Hope Foster, Tracy Miner and Brian Dunphy, this second part in our ongoing series reviewing health care fraud enforcement activities in 2011 and monitoring enforcement in 2012, expands… Continue Reading
Government Health Care Enforcement: How 2011 Actions Are Impacting 2012 Priorities
Posted in Fraud & Abuse, Pharma & Medical Devices, State & Federal Audits, Investigations & LitigationHealth care providers and pharmaceutical and medical device manufacturers are operating in an environment of intense scrutiny. As discussed in a Mintz Levin client advisory, in 2011, the federal government directed extraordinary resources and attention to detecting and prosecuting health care fraud and abuse. Numerous law enforcement agencies are casting a wide net and are… Continue Reading
District Court Allows Trial on Whether a Below Cost but Competitively Bid Arrangement Can Lead to a Kickback Violation
Posted in Fraud & Abuse, State & Federal Audits, Investigations & LitigationWritten by Kevin McGinty The recent decision by a federal court judge in Mississippi to deny defendants’ motion for summary judgment in United States ex rel. Jamison v. McKesson rejected a well-established defense to claims that competitively procured arrangements for goods and services constituted “remuneration” for purposes of the Anti-Kickback Statute (“AKS”). Where it has… Continue Reading
CMS Publishes Proposed Rule on Return of Medicare and Medicaid Overpayments
Posted in Fraud & Abuse, Health Care Reform, ReimbursementWritten by Karen S. Lovitch and Stephanie D. Willis Health care providers and suppliers concerned about how the Centers for Medicare & Medicaid Services (CMS) plans to implement the 60-day deadline for returning Medicare and Medicaid overpayments enacted as part of the Affordable Care Act (ACA) now have a proposed rule that provides some insight…. Continue Reading
OIG Warns Physicians of Fraud Liability from Medicare Reassignments
Posted in Fraud & Abuse, Physicians, Reimbursement, State & Federal Audits, Investigations & Litigation, UncategorizedWritten by Karen S. Lovitch and Stephanie D. Willis An OIG Alert issued today reminds physicians who reassign their right to submit claims to and receive payment from Medicare may be liable for any false claims submitted to the government. The OIG linked this alert to recent settlements under the Civil Monetary Penalty Law with physicians whose Medicare payment reassignments resulted in false… Continue Reading
2011-The Year In Review: Trends in Health Care Enforcement
Posted in Fraud & AbuseWritten by: Hope S. Foster, Tracy A. Miner, Brian P. Dunphy, Samantha P. Kingsbury, and Stephanie D. Willis Mintz Levin’s Health Care Enforcement Defense Group reviewed health care fraud enforcement activities in 2011 to offer a general snapshot of the environment in which health care providers and pharmaceutical and medical device manufacturers operate. This 2011 Year… Continue Reading
Sanctions Imposed For Failure to Meet Ethical Standards for Use of Privileged Documents
Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation, UncategorizedRelators and their counsel are increasingly being held accountable for the misuse of qui tam defendants’ confidential and privileged documents in connection with lawsuits alleging violations of the False Claims Act (“FCA”). In a new Health Care Enforcement Defense Group Advisory, Health Law Section Of Counsel Ellyn Sternfield and I discuss the recent decision in United States ex rel. Jerre Frazier v…. Continue Reading
CMS “Clarifies” Application of Time Limits for Processing Suspect Medicare Prescription Drug Claims
Posted in Fraud & Abuse, Payors & PBMsWritten By Susan Berson and Ellyn Sternfield Over the last several years, the federal government has sought to move from a reactive to a proactive approach to Medicare fraud enforcement. In other words, the hope is to stop fraud before it occurs rather than pay claims and then chase payments that are subsequently determined to… Continue Reading
D.C. Circuit Finds Physicians Can Pursue Challenge to Stark Law Regulation
Posted in Fraud & Abuse, Hospitals & Health Systems, Physicians, State & Federal Audits, Investigations & LitigationWritten by Tom Crane The D.C. Court of Appeals gave Medicare providers and suppliers a holiday gift last week with the issuance of a rare jurisdictional ruling involving a challenge to the Stark Law regulations. For years, CMS had interpreted the Stark Law as permitting physicians to act as service providers to hospitals furnishing an… Continue Reading
Sunshine Act: Proposed Regulations Shed Some Light on Implementation
Posted in Fraud & Abuse, Health Care Reform, Pharma & Medical Devices, PhysiciansWritten by Brian Dunphy and Karen Lovitch Pharmaceutical and medical device manufacturers, along with physicians and teaching hospitals, who have been grappling with how to implement the requirements of the federal Physician Payment Sunshine Act have finally received long-awaited guidance. Yesterday CMS published an overdue proposed rule required by the Sunshine Act that fills in some key details. … Continue Reading
Supreme Court Declines to Take Up Implied Certification Under the FCA
Posted in Fraud & Abuse, State & Federal Audits, Investigations & LitigationMedical device and pharmaceutical manufacturers and health care providers will have to wait for clarification about the extent to which courts will allow the federal False Claims Act (FCA) to be used to police underlying violations of the many statutory and regulatory requirements that apply to their operations. On December 5th, the United States Supreme Court denied… Continue Reading
A Delicate Balance for ACOs: Waiver of Fraud and Abuse Laws and New Program Integrity Requirements
Posted in Accountable Care Organizations, Fraud & Abuse, Health Care ReformHow will the waiver of certain health care fraud and abuse laws and the implementation of program integrity requirements under the new Medicare Shared Savings Program affect the formation and operation of accountable care organizations? In an article published in BNA’s Health Care Fraud Report, Tom Crane, Karen Lovitch, and I explore the delicate balance between… Continue Reading
OIG Issues 2011 Fall Semiannual Report to Congress
Posted in Fraud & Abuse, Reimbursement, State & Federal Audits, Investigations & Litigation, UncategorizedWritten by Stephanie D. Willis The OIG’s 2011 Fall Semiannual Report describes the actions the agency undertook between April 1 and September 30, 2011 and summarizes its Medicare and Medicaid claims reviews and its legal, investigative, and monitoring activities. These monitoring activities now employ the enhanced “data mining, predictive analytics, trend evaluation, and modeling” technology discussed… Continue Reading
OIG Approves Arrangement Based on New Exception to Beneficiary Inducement Prohibition
Posted in Fraud & Abuse, Hospitals & Health SystemsWritten by Karen Lovitch and Stephanie Willis In OIG Advisory Opinion 11-16, the OIG found that a Domiciliary Services Program (the “Program”) offered by a non-profit research hospital (the “Requestor”) is protected from enforcement under the Anti-Kickback Statute and the prohibition on beneficiary inducement found in the civil monetary penalties law (the “CMP law”). Through the Program, the Requestor (described… Continue Reading
OIG Study Finds Vulnerabilities in ZPIC Data
Posted in Fraud & Abuse, State & Federal Audits, Investigations & Litigation, UncategorizedThe OIG has released a Report that shows inaccuracies and a lack of uniformity in data used by the ZPICs (Zone Program Integrity Contractors) resulting from system issues in CMS ARTS, ZPIC reporting errors, ZPICs’ interpretations of workload definitions, and inconsistencies in requests for information reports. Inaccuracies and lack of uniformity prevented the OIG from making… Continue Reading
